23 April 2008
Draft
Annex 13 Released: Section 44 Reworded to Enhance Understanding of the
Two-Step Release Procedure
Based on practical experiences a revision of the Annex 13
(Investigational Medicinal Products) was deemed necessary to clarify
certain points related to reference and retention samples, the two-step
release procedure for investigational medicinal products and to the
principle of independence between production and quality control
functions.
Comments should be sent to entr-gmp@ec.europa.eu and
GMP@emea.europa.eu
by 31 October 2008.
The following changes are proposed for Annex 13:
- A minor change has been made to section 3 in order to reinforce the
principle of independence between production and quality control
functions in cases where the number of personnel involved is small.
- Changes are proposed to sections 36 and 37 to supplement, for
investigational medicinal products, the guidance for reference and
retention samples given in Annex 19.
- Section 44 has been reworded to enhance understanding of the two-step
release procedure that applies to investigational medicinal products.
It is now more clearly defined that the sponsor should ensure that the
details set out in the clinical trial application and considered by the
Qualified Person are consistent with what is finally accepted by the
competent authorities. Suitable arrangements to meet this requirement
should be established. In practical terms, this can best be achieved
through a change control process for the Product Specification File and
defined in a Technical Agreement between the QP and the sponsor.
View the guideline
Annex 13 (Investigational Medicinal Products) for further information.
Compiled by:
Wolfgang Schmitt
On behalf of the European QP Association
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